Cite as: 529 U. S. 120 (2000)
Breyer, J., dissenting
directions when regulated so as to render it as harmless as possible. And surely the agency can determine that a substance is comparatively "safe" (not "dangerous") whenever it would be less dangerous to make the product available (subject to regulatory requirements) than suddenly to withdraw it from the market. Any other interpretation risks substantial harm of the sort that my sleeping pill example illustrates. See supra, at 174-175. And nothing in the statute prevents the agency from adopting a view of "safety" that would avoid such harm. Indeed, the FDA already seems to have taken this position when permitting distribution of toxic drugs, such as poisons used for chemotherapy, that are dangerous for the user but are not deemed "dangerous to health" in the relevant sense. See 61 Fed. Reg. 44413 (1996).
The tobacco companies point to another statutory provision which says that if a device "would cause serious, adverse health consequences or death, the Secretary shall issue" a cease distribution order. 21 U. S. C. § 360h(e)(1) (emphasis added). But that word "shall" in this context cannot mean that the Secretary must resort to the recall remedy whenever a device would have serious, adverse health effects. Rather, that language must mean that the Secretary "shall issue" a cease distribution order in compliance with the section's procedural requirements if the Secretary chooses in her discretion to use that particular subsection's recall remedy. Otherwise, the subsection would trump and make meaningless the same section's provision of other lesser remedies such as simple "notice" (which the Secretary similarly can impose if, but only if, she finds that the device "presents an unreasonable risk of substantial harm to the public"). § 360h(a)(1). And reading the statute to compel the FDA to "recall" every dangerous device likewise would conflict with that same subsection's statement that the recall remedy "shall be in addition to [the other] remedies provided" in the statute. § 360h(e)(3) (emphasis added).
177
Page: Index Previous 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 NextLast modified: October 4, 2007